ISO 8638:2004
(Main)Cardiovascular implants and artificial organs — Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
Cardiovascular implants and artificial organs — Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
ISO 8638:2004 specifies requirements for single-use extracorporeal blood circuits (hereafter referred to as "the device") and (integral and non-integral) transducer protectors which are intended for use in haemodialysis, haemodiafiltration and haemofiltration. ISO 8638:2004 is not applicable to haemodialysers, haemodiafilters or haemofilters, plasmafilters, haemoperfusion devices, vascular access devices, blood pumps, pressure monitors for the extracorporeal blood circuit, air detection devices, systems to prepare, maintain or monitor dialysing fluid, or systems intended to perform haemofiltration or haemoconcentration. Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637.
Implants cardiovasculaires et organes artificiels — Circuit sanguin extracorporel pour les hémodialyseurs, les hémodiafiltres et les hémofiltres
General Information
Relations
Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 8638
Second edition
2004-10-01
Cardiovascular implants and artificial
organs — Extracorporeal blood circuit for
haemodialysers, haemodiafilters and
haemofilters
Implants cardiovasculaires et organes artificiels — Circuit sanguin
extracorporel pour les hémodialyseurs, les hémodiafiltres et les
hémofiltres
Reference number
ISO 8638:2004(E)
©
ISO 2004
---------------------- Page: 1 ----------------------
ISO 8638:2004(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall
not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the
unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
© ISO 2004
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
©
ii ISO 2004 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 8638:2004(E)
Contents Page
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 2
4.1 Biological safety . 2
4.2 Sterility . 2
4.3 Nonpyrogenicity . 2
4.4 Mechanical characteristics . 3
4.5 Expiration date . 5
4.6 Tubing compliance . 5
5 Test methods . 5
5.1 General . 5
5.2 Biological safety . 6
5.3 Sterility . 6
5.4 Nonpyrogenicity . 6
5.5 Mechanical characteristics . 6
5.6 Expiration date . 9
5.7 Tubing compliance . 9
6 Labelling . 9
6.1 Labelling on the device . 9
6.2 Labelling on the unit container . 10
6.3 Labelling on the outer container . 10
6.4 Accompanying documentation . 10
Bibliography . 12
©
ISO 2004 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO 8638:2004(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International
Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 8638 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 2,
Cardiovascular implants.
This second edition cancels and replaces the first edition (ISO 8638:1989), which has been technically revised.
©
iv ISO 2004 – All rights reserved
---------------------- Page: 4 ----------------------
ISO 8638:2004(E)
Introduction
This International Standard is concerned with extracorporeal blood circuits manufactured for single use and
intended for use in conjunction with haemodialysers, haemodiafilters and haemofilters. The requirements
specified in this International Standard for extracorporeal blood circuits will help to ensure their safety and
satisfactory function.
It was not found practicable to specify materials of construction. This International Standard therefore requires
only that materials have been tested and that the methods and results are made available upon request.
The dimensions of the connectors intended for connecting the extracorporeal blood circuit to a haemodialyser,
haemodiafilter or haemofilter have been specified to ensure compatibility with these devices, as specified in
ISO 8637. The design and dimensions have been selected in order to minimize the risk of leakage of blood and
ingress of air. Connectors with either fixed or loose locking shells are permitted.
This International Standard reflects the consensus of physicians, manufacturers and other interested parties for
devices that are approved for clinical use. Conformance with this International Standard is voluntary and it is not
intended to supersede any national regulation.
©
ISO 2004 – All rights reserved v
---------------------- Page: 5 ----------------------
.
vi
---------------------- Page: 6 ----------------------
INTERNATIONAL STANDARD ISO 8638:2004(E)
Cardiovascular implants and artificial organs — Extracorporeal
blood circuit for haemodialysers, haemodiafilters and
haemofilters
1Scope
This International Standard specifies requirements for single-use extracorporeal blood circuits (hereafter
referred to as "the device") and (integral and non-integral) transducer protectors which are intended for use in
haemodialysis, haemodiafiltration and haemofiltration.
This International Standard is not applicable to
— haemodialysers, haemodiafilters or haemofilters,
— plasmafilters,
— haemoperfusion devices,
— vascular access devices,
— blood pumps,
— pressure monitors for the extracorporeal blood circuit,
— air detection devices,
— systems to prepare, maintain or monitor dialysing fluid,
— systems intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration.
NOTE Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in
ISO 8637.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced document
(including any amendments) applies.
ISO 594-2, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment —
Part 2: Lock fittings
ISO 7864, Sterile hypodermic needles for single use
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing
ISO 10993-4, Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
ISO 10993-7, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
ISO 10993-11, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
©
ISO 2004 – All rights reserved 1
---------------------- Page: 7 ----------------------
ISO 8638:2004(E)
3.1
extracorporeal blood circuit
blood tubing and integral accessory tubing, including fluid and infusion tubing, for attaching the extracorporeal
blood circuit to pressure monitors and integral components
NOTE Examples of integral components are: air-capture chambers, transducer protectors.
3.2
fluid pathway
internal surfaces of the extracorporeal blood circuit
3.3
labelling
written, printed, graphic or electronic matter which is:
— affixed to a medical device or any of its containers or wrappers, or
— accompanying a medical device, and is related to identification, technical description and use of the medical
device, but excluding shipping documents
3.4
pump segment
portion of the extracorporeal blood circuit that is acted upon by the blood pump
3.5
transducer protector
pressure-transmitting sterile barrier
component of the extracorporeal blood circuit that is intended to provide an interconnection between the
extracorporeal blood circuit and the haemodialysis machine while allowing the pressure within the
extracorporeal blood circuit to be measured by the machine
3.6
air-capture chamber
drip chamber
bubble trap
venous and arterial blood chamber
component intended to capture air and which may provide compliance to the blood circuit or allow pressure to
be monitored
4 Requirements
4.1 Biological safety
Parts of the device that are intended to come into direct or indirect contact with blood shall be evaluated for
freedom from biological hazards, in accordance with 5.2. If the device is labelled for reuse, testing shall be
performed after reprocessing following the manufacturer's instructions for use.
NOTE Attention is drawn to the need to establish whether national regulations or national standards governing toxicology
and biocompatibility testing exist in the country in which the device is produced and, if applicable, in the countries in which
the device is to be marketed.
4.2 Sterility
The blood pathway of the device shall be sterile. Compliance shall be verified in accordance with 5.3.
4.3 Nonpyrogenicity
The blood pathway of the device shall be nonpyrogenic. Compliance shall be verified in accordance with 5.4.
©
2 ISO 2004 – All rights reserved
---------------------- Page: 8 ----------------------
ISO 8638:2004(E)
4.4 Mechanical characteristics
4.4.1 Structural integrity
The device shall be capable of withstanding a positive pressure of 1,5 times the recommended pressure and a
negative pressure not exceeding 700 mmHg (or 93,3 kPa below atmospheric pressure), or the highest
obtainable sub-atmospheric pressure if at high elevation, when tested according to 5.5.1.
4.4.2 Connection to haemodialyser, haemodiafilter or haemofilter
4.4.2.1 Except where the haemodialyser, haemodiafilter or haemofilter and the extracorporeal blood circuit are
designed as an integral system, the dimensions of the connectors for the haemodialyser, haemodiafilter or
haemofilter shall be as given in Figure 1. Compliance shall be verified in accordance with 5.5.2.
4.4.2.2 Connectors made of semi-rigid materials shall meet the performance requirements of ISO 594-2.
Dimensions in millimetres
Figure 1 — Main fitting dimensions of extracorporeal blood circuit connector to blood ports
of haemodialyser, haemodiafilter or haemofilter
4.4.3 Connection to vascular access device
Except where the extracorporeal blood circuit and the vascular access device are an integral system, the
connector intended for connection to vascular access devices shall be a male 6% (Luer) taper lock fitting in
accordance with ISO 594-2.
Compliance shall be verified in accordance with 5.5.3.
©
ISO 2004 – All rights reserved 3
---------------------- Page: 9 ----------------------
ISO 8638:2004(E)
4.4.4 Connection to ancillary components
All parts of the extracorporeal blood circuit intended for use with non-integral ancillary components, such as
heparin lines, pressure-transducer lines, medication-administration lines and level-adjustment lines, shall
terminate in fittings which meet the performance requirements of ISO 594-2 taper lock fittings. Compliance shall
be verified in accordance with 5.5.4.
4.4.5 Colour coding
The arterial patient-connection end shall be colour-coded red, and the venous patient-connection end shall be
colour-coded blue. The coding shall be prominently displayed within 100 mm of the end of the tubing.
Compliance with this requirement shall be verified in accordance with 5.5.5.
4.4.6 Access ports
4.4.6.1 Needle access ports
Needle access ports shall not leak when tested in accordance with 5.5.6.1. The access ports shall be designed
so as to minimize the risk of the needle piercing the tube completely and causing injury.
4.4.6.2 Needleless access ports
Needleless access ports shall not leak when tested in accordance with 5.5.6.2.
4.4.6.3 Access port location
Access ports shall not be located downstream of the location intended for the air detector.
4.4.7 Blood pathway volume
The range of the volume of blood pathway in the extracorporeal blood circuits shall be specified by the
manufacturer. Compliance with this requirement shall be verified in accordance with 5.5.7.
NOTE The blood pathway volume is also known as the priming volume.
4.4.8 Air-capture chamber fill level
The recommended fill level of the air-capture chamber shall be marked as applicable on the air-capture
chamber. Compliance with this requirement shall be verified in accordance with 5.5.8.
4.4.9 Transducer protectors
4.4.9.1 Integral transducer protectors
Extracorporeal blood circuits supplied with integral transducer protectors shall be capable of preventing cross-
contamination. The transducer protector shall be capable of maintaining secure and leak-free connection to the
haemodialysis machine when subjected to pressures of 1,5 times the manufacturer's recommended pressure
for the device. The machine side of the transducer protector shall be transparent (clear) to allow visual
inspection of blood for contamination during use. Compliance with this requirement shall be verified in
accordance with 5.5.9.
©
4 ISO 2004 – All rights re
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.